Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease

May 12, 2025 updated by: Jason Longhurst, St. Louis University
This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region. The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens. Participants in the program will use Nordic walking poles during the walks. The walking group(s) will meet once per week and will be supervised by walking group leaders from Saint Louis University. Participants will be given a smart watch to wear that will help step counts will be tracked in real-time. The program is designed to get people with Parkinson's disease out of their homes, cultivate a culture of connection with others with Parkinson's disease, and to be collectively accountable for a common goal toward increasing their physical and social engagement in their communities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Recruiting
        • Integrated Health and Movement Science Laboratory, Saint Louis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 30-85 years old
  • Neurologist-diagnosed Parkinson's disease
  • Able to walk independently with or without a walking aid (e.g., cane, walker)
  • Willing to participate in study for at least 6 months

Exclusion Criteria:

  • Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
  • Additional neurologic disease or injury beyond Parkinson's disease.
  • Evidence of significant cognitive impairment. This will be determined by completing the Montreal Cognitive Assessment
  • Participants with poor walking ability (determined using the Timed Up and Go Test during initial testing).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Attend group community walking program for 60 minutes each week
Participants will participate in one, 60-minute group walk using Nordic poles at the Missouri Botanical Gardens for at least 6 months, with an optional continuation upto 12 months. Participants will be assessed before the program begins, after 6-months, and after 12 months. Falls will be prospectively collected for 6 months following completion of the program.
Behavioral: Community Walking Program
This is a group, community walking program at local parks using Nordic walking poles. Participants will be encouraged to walk briskly but safely for 60 minutes one time per week with the ultimate goal of using this community walking program to drive behavioral change (increased physical and social engagement in their communities) throughout the week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enrollment - Feasibility
Time Frame: Through enrollment of all the study participants
The percentage of eligible participants that enroll in the study.
Through enrollment of all the study participants
Attendance - Feasibility
Time Frame: Enrollment through the 6- and 12-month endpoints
The percentage of attended walking program session across all enrolled participants.
Enrollment through the 6- and 12-month endpoints
Safety/Rate of Falls - Feasibility
Time Frame: From enrollment to both the 6 and 12 month endpoints
The rate falls related to walking program participation.
From enrollment to both the 6 and 12 month endpoints

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Steps per Day
Time Frame: From baseline assessment through the the end of the fall reporting period at 18 months
This outcome will be captured via wearable sensors worn through the duration of study participation.
From baseline assessment through the the end of the fall reporting period at 18 months
Balance Discordance
Time Frame: From baseline assessment through the 6- and 12-month endpoints
This is the difference between actual balance confidence (captured via the activities specific balance confidence scale) and predicted balance confidence (modeled from time to complete the Timed Up and Go Test).
From baseline assessment through the 6- and 12-month endpoints
Loneliness
Time Frame: From baseline assessment through the 6- and 12-month endpoints
Assessed with the 20 item UCLA loneliness scale in which subjects rate the degree of loneliness that they experience in daily life. The scale has a minimum score of 20 and maximum score of 80 with higher scores indicating that the individual is experience more loneliness.
From baseline assessment through the 6- and 12-month endpoints
Social Connection
Time Frame: From baseline assessment through the 6- and 12-month endpoints
Assessed with the Berkman-Syme Social Network Index, an 11-item questionnaire in which participants rate their perceived social network and isolation. The index has a minimum score of zero and maximum score of 11 with higher score indicating a larger and stronger social network.
From baseline assessment through the 6- and 12-month endpoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Louis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 34235

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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